The past, present, and future of the regulatory affairs executive
In 2026, regulatory affairs professionals are represented more than ever in C-suites and boardrooms across the world. But that didn’t happen overnight.
As part of RAPS 50th anniversary, we spoke with Sherry Keramidas, our society’s executive director from 1996 to 2016, about how regulatory affairs slowly made its way from ignored to included, and what needs to happen next.
RAPS: How has the leadership role in regulatory affairs evolved over time? What was the journey like earlier in the profession’s history from lower-level to eventually getting representation in the C-suite (or close to it)?
Sherry Keramidas: In our Scope of Practice Survey, we started seeing indicators that regulatory professionals were taking on more business and executive functions. They were just little signs: interfacing more with marketing, having conversations with someone in the C-suite, or providing information to a company’s financial advisors.
RAPS began to capture that and study it over and over again. It was quite clear that many people in organizations were reaching out to the regulatory team members. But most regulatory people have a scientific, clinical, or technical background. The language that they speak was, and still is, very different. And very often it became a difficult conversation. A lot of regulatory people did not feel comfortable sitting with a chief marketing officer, or a CFO, or a CEO. So, we began to say, “How do we provide them exposure to the skillset that would allow them to feel comfortable and eventually allow them to perhaps negotiate a seat at the C-suite table?”
Finding the right time and setting to learn those business skills is where RAPS really came in. As we started to have this yearly cohort of Kellogg Executive Development Program alumni, we began to track their progress. What we began to see was that a number of graduates were moving up. Some of them were moving into senior regulatory roles, but we also began to see alumni elevated into VP roles and even positions in the C-suite.
In your view, what are the most important skills you think people were getting out of this Kellogg program?
This was true 25 years ago and is true today: leaders need to be able to see the big picture. They need to be able to look at an environment and analyze before they make a decision — and that analysis should not only be driven by data. Data is really important. I don't want to in any way lessen the importance of data, especially in regulatory.
But there are other components that help us understand the environment, the situation, the organization, that are not always data driven. When you're trained as a scientist, an engineer, or a clinician, you're educated to look at data and look at facts. You're skilled to collect information and then put it into some kind of logical order to make a decision. Sometimes that limits our ability to see a broader picture. And that's what I believe personally is required for leaders today, whether they're leading within their profession, within their job title, or leading more broadly. And again, it's not that regulatory people don't have that ability, but their training to acquire these knowledge and skills to perform this important function is heavily data-driven and technically oriented and precise. They need to step back a little bit and acquire the confidence to look more broadly so they can put their data-driven lens on top of this broader lens. I think this kind of training gives them the confidence to do this. It gives them the terminology to communicate with others. And I think that's the power of programs like the RAPS Kellogg Executive Development Program.
How do you see the regulatory executive position evolving in the future?
We still definitely have some progress to make. At RAPS’ 25th anniversary, I can remember our focus on moving from thinking of regulatory as a job function into a real profession. A profession meant that you had ethical standards; you had professional standards, you had growth possibilities. You weren’t just a narrow job function, because that only got you so far.
I think it's still a science, a technical and data-based profession. The extra work that it takes to break away from that, to facilitate a wide view in an organization, is challenging. When you are a person who enjoys the data, it's very hard to step away and say, “I need to look at things beyond the data that may shape strategy going forward." I think further developing those leadership capabilities will take time for many regulatory professionals. But as I said, there are many regulatory affairs professionals who have gone beyond this to achieve great success and who are still realizing that success.
And quite frankly, leadership is changing right now. So regulatory isn't too far behind anybody else. I think the whole demeanor and requirements for a leader have changed drastically. One thing that has changed drastically, and it may be a little bit difficult for some regulatory people, is that the command and control approach to leadership is pretty much gone. Although we see shades of it in some places, in organizations that are really going to survive and be effective in the future, that kind of structure isn't going to work. In regulatory, there is a mini command and control because you were the person who had a big regulatory agency or agencies behind you to have that stick. They gave you the stick to kind of slap over the wrist of the marketing staff or other folks. But that kind of approach is changing now. And I think the regulatory people are going to have to learn this just like many other people have done. Moving forward, I think it's helping regulatory people remain flexible and agile in their profession. Again, it's stepping away somewhat from the data and moving into a more flexible structure.
Obviously, regulatory is going to be impacted by AI and other kinds of things. And how is that going to affect decision making? How is it going to affect the quality of information? That's going to be something that they're going to have to deal with just like everybody else. So, it's in this world in chaos and constant change, that we have to do our best to do our job well and still keep up with all of that.
Ready to take the next step in your regulatory leadership journey?
The RAPS Kellogg Executive Development Program prepares regulatory professionals to lead teams, make hard decisions, and ultimately contribute to better business outcomes.